AMIL Care products for the medical sector are intended for the sanitization of surfaces such as equipment, operating tables, medical units, and of a precise category of devices: non-invasive medical devices.
We believe it is important to give an exhaustive explanation, and we will do so in this article, designed for all professionals, referring in particular to professional figures such as the Purchasing Manager in hospital facilities, the Medical Equipment Management Managers, Clinical Engineers (Aiic), Heads of safety and hygiene (HSE), and also Heads of clinical risk management.
What is a medical device?
A medical device is any instrument, appliance, implant, substance, or other product used alone or in combination, for diagnostic and/or therapeutic purposes. Its main action is not achieved by pharmacological means.
All medical devices are classified according to their complexity and potential risk for the patient.
The manufacturer of a device must indicate its intended use, from which will derive more specific characteristics, such as invasiveness, dependence, or nonreliance on an energy source, and contact time with the body.
Based on these characteristics, the classification will be assigned according to the rules set out in Attachment IX, Legislative Decree no. 46 of 24 February 1997.
The classification of medical devices distinguishes class I, class IIa, class IIb, and class III.
Class I corresponds to the so-called “low-risk” devices, such as bandages, wheelchairs, scalpels, and corrective glasses. Furthermore, two sub-categories are Is, for devices supplied in a sterile state, and Im, for devices with a measuring function.
Class Ila corresponds to devices with “medium-low risk”, such as suture needles, forceps, and disinfectants for non-invasive medical devices.
Class Ilb corresponds to devices with “medium-high risk”, such as incubators for newborns, dialysis instruments, and surgical lasers.
Finally, class IlI corresponds to devices with “high risk”, such as absorbable sutures and bone and tissue substitutes of animal origin.
Among the above classes, it is also possible to see a broader distinction between invasive and non-invasive medical devices.
The first are those intended to penetrate the orifices of the body and are surgical or implantable devices inside the body. The latter, on the other hand, do not penetrate any part of the body.
On the basis of the duration of use, the following are distinguished:
- devices for temporary use if the expected continuous duration is less than 60 minutes;
- devices for short-term use if the expected continuous life does not exceed 30 days;
- devices for long-term use if the continuous duration is more than 30 days.
For further information, it is possible to read the Health Notebook that the Ministry of Health has dedicated to the topic, number 17.
Non-invasive medical devices: what are they?
What are non-invasive medical devices (DN)? As can be imagined from the description above, non-invasive medical devices are in class I, involving low risk to health.
However, there are exceptions, always indicated in Annex IX, Legislative Decree n. 46 of 24 February 1997.
In particular, non-invasive devices intended for the channeling or storage of blood, body liquids or tissues, or liquids or gases intended for transfusion, administration, or introduction into the body, are in some cases classified as class IIa.
In addition, non-invasive devices designed to modify the biological or chemical composition of blood, or other body fluids or intended for transfusion into the body are in class IIb, unless such treatment consists of filtering, centrifugation, or exchange of gases or heat.
Finally, some non-invasive devices intended to come into contact with injured skin can fall into class IIa or class IIb, depending on how they are used.
Therefore, the same type of device may fall into one class or another, depending on its use. Take the example of gauze: if it is used and designed as a barrier for dressing intact or injured skin, it falls under class I. On the other hand, if it is used in surgery, it falls under class IIa.
The “actors” of the production and the certifications
In the production of a medical device, we always have a manufacturer and an authorized representative.
The former is the natural or legal person responsible for the device’s design, manufacture, packaging, and labeling.
The authorized representative, on the other hand, is the natural or legal person who, expressly designated by the manufacturer, acts, and may be consulted on his behalf by the competent national authorities and community bodies regarding obligations related to the production and distribution of the device.
In particular, all medical devices can be placed on the market in the European Union after obtaining the CE certification. This document guarantees that the product has undergone conformity assessment procedures which certify its compliance with the essential requirements of the reference directive.
How does the CE certification process take place?
How does the CE certification process take place? First, the classification of medical devices is done according to the rules explained above. Then the design and manufacturing processes are evaluated and tests of compliance with essential requirements are performed on the products. For device classes above I, the relevant certificates issued by notified bodies are obtained. Finally, the conformity of the labels is checked, and if everything is in order, we proceed with the written declaration of conformity and the affixing of the CE mark.
CE-marked products do not have to undergo additional checks before being placed on the market.
The only devices that do not have to achieve CE certification are custom-made devices and devices for clinical investigations.
The information leaflet, optional for class I and Ila devices, must also include precise data, such as the intended use, the expected performance and any side effects, information relating to installation and maintenance and associated risks, and the instructions for cleaning, disinfection, and packaging.
All medical devices marketed in Italy must also be registered in the database of the Ministry of Health as required by the Ministerial Decree of 21 December 2009.
AMIL Care products for sanitizing non-invasive medical devices
To ensure the efficacy and safety of healthcare treatment, medical devices must be constantly subjected to professional sanitization processes in addition to meeting the essential manufacturing requirements.
AMIL Care has always supported this goal, thanks to the production and marketing of non-active medical devices intended for the disinfection of non-invasive medical devices and surfaces such as equipment, operating tables, and medical units.
The production of AMIL Care makes use of the Medisystem, the combination of a series of devices intended for the sanitization of healthcare environments and more, based on hydrogen peroxide and silver salts.
The basic device is a portable, simple-to-use micro nebulizer in different configurations.
The Basic device makes it possible to micro-nebulize particles from 1 to 5 microns, it is configurable and is suitable for use in medical and healthcare surgeries, with 15 different programs. The Basic Dental version is instead intended for dental surgeries. The other models are Medibios Plus, with advanced features for the hospital sector and configurability for different environments, and Medibios Plus Hub, which acts for the sanitization of hospital areas with IR recognition of the environments.
The AMIL Care Medisystem environmental sanitization range is completed by other devices intended for the food and pharmaceutical sectors.
The professionalism of AMIL Care products is guaranteed by the UNI EN ISO 9001 and UNI CEI ISO 13485 certifications.